BlueCross BlueShield of Tennessee Medical Policy Manual

Durvalumab

NDC CODE(S)

0310-4500-12 Imfinzi 120 mg / 2.4 mL SOLN - Astra Zeneca

 

0310-4611-50 Imfinzi 500 mg / 10 mL SOLN - Astra Zeneca

DESCRIPTION

Durvalumab is a human immunoglobulin G1 kappa monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 and CD80 (B7.1) molecules.  This PD-L1 blocking antibody binds to receptors on both tumor cells and tumor-associated immune cells in the tumor microenvironment, releasing the inhibition of immune responses without inducing antibody dependent cell-mediated cytotoxicity (ADCC).  PD-L1 blockade leads to increased T-cell activation and decreased tumor size.  

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Urothelial carcinoma   10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCE

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. IMFINZI™ (durvalumab) injection, for intravenous use. Retrieved May 1, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/1/2017

MOST RECENT REVIEW DATE:  6/1/2017

ID_MRxEx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Durvalumab (Imfinzi)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 18 years of age or older with a diagnosis of locally advanced or metastatic urothelial carcinoma?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the disease shown ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested dosing 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity for a 6 month authorization period?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request meet the criteria in question #4 with the absence of unacceptable toxicity including, but not limited to, Immune-Mediated Hepatitis; Immune-Mediated Colitis; Immune-Mediated Endocrinopathies including  Thyroid Disorders, Adrenal Insufficiency, Type 1 Diabetes Mellitus, Hypophysitis; Immune-mediated Rash; Infections; Immune Thrombocytopenic Purpura; Nephritis?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.